A Study of Surgical Interventions in Fistulizing Conditions (NCT04940611) | Clinical Trial Compass
CompletedNot Applicable
A Study of Surgical Interventions in Fistulizing Conditions
United States, Austria, Belgium646 participantsStarted 2021-08-05
Plain-language summary
In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice.
The aim of the study is to generate real-world evidence on standard of care for surgical interventions and related outcomes when treating complex fistulizing conditions.
The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. CPF-CD that meets one or more of the following criteria:
. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
. Complex cryptoglandular fistula that meets one or more of the following criteria:
. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
Exclusion criteria
. Current participation in interventional clinical trials.
. Has CPF-CD: fistula connection to bladder or another organ
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants who Achieve Clinical Remission of Fistula